对前3批《鼓励仿制药品目录》中新型药物制剂的药学研究的思考  

Pharmaceutical considerations on novel pharmaceutical preparations in China encourage generic drug catalogue(first to third batches)

作　　者：司晓菲 孙桂霞 张保梅 戴田行 葛妍秀 姜典卓 SI Xiao-fei;SUN Gui-xia;ZHANG Bao-mei;DAI Tian-xing;GE Yan-xiu;JIANG Dian-zhuo(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《中国临床药理学杂志》2025年第1期143-148,共6页The Chinese Journal of Clinical Pharmacology

摘　　要：为及时满足国内临床用药需求,国家卫生健康委员会等发布了3批《鼓励仿制药品目录》,对完善仿制药保障供应水平,提高用药可及性起到良好的引导作用。本研究通过检索相关国内外审评报告和文献,分析了目录中典型的新型药物制剂,对其药学研究关注的处方工艺和质量控制等进行探讨思考,为仿制药开展相关研究开发提供科学参考依据。To meet the domestic clinical demand timely,the national health commission has released three batches of encourage generic drug catalogues,which plays a good guiding role in improving the supply level and accessibility of generic drugs.Based on literature investigation,the typical cases of novel pharmaceutical preparations were analyzed,and the pharmaceutical considerations were put forward in terms formulation,manufacturing process and quality control,aimed to provide scientific reference for research and development of such drugs.

关 键 词：鼓励仿制药品目录 新型药物制剂 处方工艺 质量控制 药学研究 

分 类 号：R95[医药卫生—药学]